Amitiza denials: what the review data shows

Where the denial was overturned

A 57-year-old female enrollee has requested Amitiza 24 mcg, twice per day for treatment of her chronic constipation. Findings: The physician reviewer found that the records submitted for review substantiate that this patient meets the Rome III criteria for the diagnosis of chronic constipation with symptoms persisting throughout her lifetime. The records suggest her chronic constipation has worsened and her provider has prescribed Amitiza 24 mcg twice a day to treat her chronic constipation. According to the medical literature, chronic constipation is the most common gastrointestinal complication of long-standing diabetes. Because of her diabetes, she likely has slow transit constipation. Recently, Wald published results indicating that fiber therapy (i.e. Metamucil, Citrucel, calcium polypcarbophil) will likely worsen constipation in patients with this type of condition.

A patient has requested authorization and coverage for Amitiza. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the patient’s irritable bowel syndrome with constipation. The submitted documentation supports the medical necessity of the requested medication. The use of an osmotic laxative (Miralax) has not been successful for this patient. The American Gastroenterological Association states that the first line of therapy should be an osmotic agent, and then another type of laxative, such as a stimulant laxative, should be tried before a newer agent such as Linzess or Amitiza is considered, as the newer agents have more adverse effects. In this case, a stimulant laxative (senna) was not effective, and an osmotic laxative (Miralax) was not effective.

Where the denial was upheld

Findings: The physician reviewer found that an enrollee has requested authorization and coverage for Amitiza 24mcg capsules. The submitted documentation does not support that the requested medication is medically necessary. The requested Amitiza dose of 24mcg, twice daily, is supported for chronic idiopathic constipation only. The recommended dose for irritable bowel syndrome, with constipation-predominant, is 8mcg, twice daily. Furthermore, research shows that for constipation, the first line of therapy should be an osmotic agent, and then another type of laxative such as a stimulant laxative should be tried before a newer agent such as Amitiza is considered, as the newer agents have more adverse effects.

A patient has requested authorization and coverage for Amitiza 8 mcg capsules. Findings: The physician reviewer found that all patients with predisposing factors should be considered for prophylactic laxative therapy when opioid treatment is initiated. Conventionally, this is accomplished with a contact cathartic (such as senna), with or without a stool softener, or daily administration of an osmotic laxative (such as lactulose). All patients should be encouraged to increase fluid intake, mobility, and dietary fiber. There are numerous options for laxative therapy and no data to suggest that any one approach is superior to any other. In a systematic review of management of opioid induced constipation in a population with advanced illness, four randomized trials comparing different kinds of laxatives showed no significant differences among them.

These are outcomes from California’s external review program — an independent physician panel that binds the insurer. Every state has an equivalent process, and internal appeals succeed even more often. Cite the outcome record for Amitizawhen you appeal: reviewers routinely find that denials like yours didn’t hold up.